Randomised comparison of three weight control programmes during adjuvant treatment for early breast cancer (Breast - Activity and Healthy Eating After Diagnosis)
| ISRCTN | ISRCTN68576140 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68576140 |
| ClinicalTrials.gov number | NCT00869466 |
| Secondary identifying numbers | 5102 |
- Submission date
- 31/03/2010
- Registration date
- 31/03/2010
- Last edited
- 21/09/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Michelle Harvie
Scientific
Scientific
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom
Study information
| Study design | Randomised interventional multicentre process of care trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Scientific title | Randomised comparison of three weight control programmes during adjuvant treatment for early breast cancer (Breast - Activity and Healthy Eating After Diagnosis) |
| Study acronym | B- AHEAD |
| Study objectives | To determine whether individualised weight control programmes are better than standard written advice for existing weight and preventing weight gain in first year after breast cancer treatment for women with early breast cancer. |
| Ethics approval(s) | First MREC approval date 09/07/2008 (ref: 08/H1013/45) |
| Health condition(s) or problem(s) studied | Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast |
| Intervention | Current interventions as of 30/04/2015: Group 1 (Control): Standard written advice This group will receive standard written diet and exercise advice. Group 2 (Intervention): Individualised home-based intervention Each woman receives individualised diet and exercise advice from the study dietitian (40 minutes) and exercise referral officer (40 minutes). This advice will be reinforced with bi-weekly phone calls (study dietitian) and mailed information during the first 12 weeks, and booster phone calls during the 12-month study. Group 3 (Intervention): Supervised group community-based weight control programme Each woman received individualised diet and exercise advice from the study dietitian (40 minutes) and exercise referral officer (40 minutes). They are then asked to attend weekly group classes for the first 12 weeks which comprise an exercise class followed by a diet and behaviour change educational component with handouts, and booster phone calls during the 12-month study. Previous interventions: Group 1 (Control): Standard written advice - This group will receive standard written diet and exercise advice. Group 2 (Intervention): Individualised home based intervention: Each woman receives individualised diet and exercise advice from the study dietitian (40 minutes) and exercise referral officer (40 minutes). This advice will be reinforced with bi-weekly phone calls (study dietitian) and mailed information during the first 12 weeks, and booster phone calls during the 12-month study. Follow Up Length: 12 month(s) Study Entry: Single Randomisation only |
| Intervention type | Other |
| Primary outcome measure | Changes in body weight and composition (body fat, fat free mass DXA, bioelectrical impedance) |
| Secondary outcome measures | Uptake and retention to the programmes and any adverse effects of the programmes. |
| Overall study start date | 11/08/2008 |
| Completion date | 02/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Planned Sample Size: 480; UK Sample Size: 480 |
| Key inclusion criteria | 1. Within 10 weeks of primary surgery for primary breast cancer (invasive or in-situ) 2. Pre and postmenopausal women of any age able to undertake interventions 3. Any weight, as programmes aim to tackle existing weight problems and prevent weight gain in healthy weight women 4. Receiving/due to start adjuvant chemotherapy, radiotherapy or endocrine therapy or no adjuvant treatment 5. Early breast cancer stages I - III 6. Ability to understand written instructions and have completed baseline 7 day diet and exercise diaries 7. Resident within Greater Manchester only in order to maximise uptake and retention to interventions and study 8. Written informed consent 9. Females, no specified age limit |
| Key exclusion criteria | 1. Metastatic or inoperable disease 2. Physical/psychiatric condition which impairs compliance or mobility assessed from medical history by recruitment nurse or verified from baseline fitness assessment by the trial physiotherapist, i.e.: 2.1. Insulin requiring diabetes, as diet and physical activity changes would require close coordination with the treating physician. Non-insulin requiring diabetics are eligible for the study. 2.2. Serious digestive and/or absorptive problems, including inflammatory bowel disease 2.3. Cardiovascular, respiratory (determined from recent pre-operative electrocardiogram [ECG], chest X-ray) disease 2.4. Musculoskeletal disease or joint problems 2.5. Psychiatric disorders or conditions, e.g., untreated major depression, psychosis, substance abuse, severe personality disorder 3. Women who regularly take daily medication known to effect body composition, e.g., corticosteroids (women receiving 2 - 3 days steroids with chemotherapy may be included) 4. Patients with metal implants, ie hip prosthesis are excluded from the study as this precludes DXA measurement of body fat (breast implants, pacemakers are not excluded) 5. Women who have received neoadjuvant chemotherapy or endocrine 6. Patients considering reconstruction surgery in the next 12 months |
| Date of first enrolment | 11/08/2008 |
| Date of final enrolment | 02/02/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
University Hospital of South Manchester NHS Foundation Trust
M23 9LT
United Kingdom
United Kingdom
The Christie Hospital NHS Trust
M20 4BX
United Kingdom
United Kingdom
Mid Cheshire NHS Foundation Trust
CW1 4QJ
United Kingdom
United Kingdom
East Cheshire NHS Trust
SK10 3BL
United Kingdom
United Kingdom
Pennine Acute Hospitals NHS Trust
M8 5RB
United Kingdom
United Kingdom
Salford Royal NHS Foundation Trust
M6 8HD
United Kingdom
United Kingdom
Stockport NHS Foundation Trust
SK2 7JE
United Kingdom
United Kingdom
Tameside Hospital NHS Foundation Trust
OL6 9RW
United Kingdom
United Kingdom
Sponsor information
South Manchester University Hospital (UK)
Hospital/treatment centre
Hospital/treatment centre
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
England
United Kingdom
| Website | http://www.uhsm.nhs.uk/Pages/default.aspx |
|---|---|
"ROR" |
https://ror.org/00he80998 |
Funders
Funder type
Government
National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | To be confirmed at a later date |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2018 | Yes | No | |
| Plain English results | 10/09/2019 | No | Yes | ||
| Results article | results | 01/09/2019 | 28/05/2020 | Yes | No |
Editorial Notes
21/09/2021: ClinicalTrials.gov number added.
28/05/2020: Publication reference added.
10/09/2019: Link to basic results added to results (plain English).
09/08/2017: Publication reference added
06/05/2015: The overall trial end date was changed from 01/12/2010 to 02/02/2012.
